Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K152602
Olea Sphere V3.0 · Olea Medical · decided 2016-03-03 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| OLEA SPHERE | 3.0 | Olea Medical USA | LLZ | EOLEOLEASPHEREV3P01 |